Recall Z-1532-2021— Medtronic Inc.
Class II · Terminated
Class II FDA medical device recall by Medtronic Inc., initiated 2021-03-16, terminated 2024-04-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.. Reason: Incorrect size printed on the device; packaging is labeled correctly..
- Recalling firm
- Medtronic Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-03-16
- Terminated
- 2024-04-15
- Firm location
- Plymouth, MN, United States
Product description
Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
Reason for recall
Incorrect size printed on the device; packaging is labeled correctly.
Data sourced from openFDA. This site is unofficial and independent of the FDA.